Fibroblast growth factor 23

Kyowa Kirin Announces European Commission (EC) Approval of CRYSVITA® (burosumab) for the Treatment of X-Linked Hypophosphataemia (XLH) in Older Adolescents and Adults

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Friday, October 2, 2020

Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin) today announced that the European Commission (EC) has approved CRYSVITA (burosumab) for use in older adolescents and adults with the rare disease X-linked hypophosphataemia (XLH).

Key Points: 
  • Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin) today announced that the European Commission (EC) has approved CRYSVITA (burosumab) for use in older adolescents and adults with the rare disease X-linked hypophosphataemia (XLH).
  • CRYSVITA was previously approved for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons.
  • With this approval, older adolescents and adults with XLH will also be able to benefit from treatment with CRYSVITA, the only therapy that targets the underlying pathophysiology of this disease.
  • Phosphate wasting and resulting hypophosphataemia in X-linked hypophosphataemia (XLH) is caused by excessive levels and activity of FGF23.

Kyowa Kirin Receives Positive CHMP Opinion for the Expanded Use of CRYSVITA® (burosumab) to Include Older Adolescents and Adults for the Treatment of X-Linked Hypophosphataemia (XLH)

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Friday, July 24, 2020

The CHMP opinion will now be reviewed by the European Commission, with a final decision expected in September 2020.

Key Points: 
  • The CHMP opinion will now be reviewed by the European Commission, with a final decision expected in September 2020.
  • The signs and symptoms of XLH begin in early childhood causing lower limb deformities, shortened stature and pain.
  • There is currently no approved therapy in Europe for older adolescents and adults with XLH that targets the underlying cause of this debilitating, progressive and life-long disease.
  • Phosphate wasting and resulting hypophosphataemia in X-linked hypophosphataemia (XLH) is caused by excessive levels and activity of FGF23.

FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening

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Thursday, June 18, 2020

The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.

Key Points: 
  • The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.
  • "Treatment for TIO focuses on identifying and removing the tumor that causes the disease.
  • FGF23 regulates levels of phosphate, an electrolyte that plays important roles in bone maintenance, energy production by cells and nerve function.
  • When there is not enough phosphate in the body, bones begin to soften and weaken, causing osteomalacia (marked softening of bones).

Ultragenyx and Kyowa Kirin Announce U.S. FDA Approval of Crysvita® (burosumab) for the Treatment of Tumor-Induced Osteomalacia (TIO)

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Thursday, June 18, 2020

The FDA approval of Crysvita marks the first treatment option that addresses the cause of the severe hypophosphatemia and osteomalacia resulting from these rare tumors, said Camille L. Bedrosian, M.D., Chief Medical Officer of Ultragenyx.

Key Points: 
  • The FDA approval of Crysvita marks the first treatment option that addresses the cause of the severe hypophosphatemia and osteomalacia resulting from these rare tumors, said Camille L. Bedrosian, M.D., Chief Medical Officer of Ultragenyx.
  • Since its approval, Crysvita has meant a great deal to patients and families that previously had no other treatment options.
  • In patients for whom the tumor or lesion is inoperable, the current treatment consists of oral phosphate and/or active vitamin D replacement.
  • InJapan, it is approved by theMinistry of Health, Labor and Welfare(MHLW) for the treatment of FGF23-related hypophosphatemic rickets and osteomalacia.

Ultragenyx and Kyowa Kirin Announce FDA Acceptance and Priority Review Designation of Supplemental Biologics License Application for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO)

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Thursday, February 27, 2020

The FDA has assigned priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of June 18, 2020.

Key Points: 
  • The FDA has assigned priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of June 18, 2020.
  • If approved, we believe Crysvita may also become a meaningful treatment option for many patients with TIO in the U.S.
  • Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone FGF23.
  • Kyowa Kirin and Ultragenyx have been collaborating in the development and commercialization of Crysvita globally based on the collaboration and license agreement between the parties.

Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO)

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Monday, January 13, 2020

The companies expect to hear back from FDA on submission acceptance and review designation in February 2020.

Key Points: 
  • The companies expect to hear back from FDA on submission acceptance and review designation in February 2020.
  • In both studies, Crysvita was associated with increases in serum phosphorus and serum 1,25-dihydroxyvitamin D levels.
  • Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone FGF23.
  • Kyowa Kirin and Ultragenyx have been collaborating in the development and commercialization of Crysvita globally based on the collaboration and license agreement between the parties.

Ultragenyx Announces Sale of Future European Royalties on Crysvita® (burosumab) for $320 Million to Royalty Pharma

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Wednesday, December 18, 2019

Once the threshold amount has been met, the EU, UK, and Switzerland royalty payments will revert back to Ultragenyx.

Key Points: 
  • Once the threshold amount has been met, the EU, UK, and Switzerland royalty payments will revert back to Ultragenyx.
  • Royalty Pharma adds a high quality asset that is an excellent addition to our diversified portfolio of leading biopharmaceutical royalties.
  • Wood Capital Advisors LLC acted as financial advisors and Gibson, Dunn & Crutcher LLP acted as legal advisor to Ultragenyx on the transaction.
  • Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone FGF23.

Ultragenyx and Kyowa Kirin Announce U.S. FDA Approves Label Update for Crysvita® (burosumab) for the Treatment of X-Linked Hypophosphatemia (XLH)

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Monday, September 30, 2019

The 64-week safety profile was similar to that observed at 40 weeks and in other Crysvita pediatric XLH studies.

Key Points: 
  • The 64-week safety profile was similar to that observed at 40 weeks and in other Crysvita pediatric XLH studies.
  • Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone fibroblast growth factor 23 (FGF23).
  • Kyowa Kirin and Ultragenyx have been collaborating in the development and commercialization of Crysvita globally based on the collaboration and license agreement between the parties.
  • Crysvita is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.

Ultragenyx and Kyowa Kirin Announce Intent to Submit Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) in Tumor-Induced Osteomalacia (TIO)

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Tuesday, September 10, 2019

The decision to submit follows the completion of a pre-sBLA meeting with the FDA and agreement on the filing package.

Key Points: 
  • The decision to submit follows the completion of a pre-sBLA meeting with the FDA and agreement on the filing package.
  • Bone scans also demonstrated an increase in healed fractures and decrease in new fractures during Crysvita treatment.
  • Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Hakko Kirin, against the phosphaturic hormone FGF23.
  • Kyowa Kirin and Ultragenyx have been collaborating in the development and commercialization of Crysvita globally based on the collaboration and license agreement between the parties.